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Sample Customer Complaint

MasterControl's Customer Complaint Systems are designed by industry practitioner for automating the Sample Customer Complaint process in any organization. A Customer Complaint system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated Customer Complaint system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.

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Get insider information about the most relevant issues in Customer Complaints today, and how to navigate and overcome the complexities of FDA and ISO Regulations.

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Automating Document Control Processes

Learn how automated document control solutions help organizations better manage corrective and preventive actions (CAPA), change control, training, and many more quality processes. It focuses on document control processes within the quality system lifecycle and provides insight into the capabilities needed to automate change control processes that will increase efficiency, ensure compliance with regulatory requirements and improve overall profitability.

Complaint Handling as an Integral Part of FDA and ISO Compliance

Effective complaint handling is not just a good business practice, but a critical compliance requirement in FDA and ISO environments. Learn the strategies and solutions for managing complaints and turn complaints-related challenges into opportunities for improvement.

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MasterControl Customer Complaints™

Discover how MasterControl Customer Complaints™ addresses the three key complaints-handling challenges of different sources, disconnected processes and an inefficient complaint process by automating complaint handling and integrating it with your quality system.

MasterControl Process™

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009.

Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.

Top 500 Software Companies 2014

Software Magazine ranks MasterControl 369 on its 2014 Software 500 list, a listing of the world's largest software and services providers. Learn More

Software Solutions Can Help Companies Simplify and Streamline the Management of Customer Complaints

Electronic customer complaint systems can improve an organization's ability to manage, record, and respond to customer complaints in the following ways:

A Centralized, Convenient System: An electronic system provides a central platform for receiving sample customer complaints and storing all subsequent documentation pertaining to investigation and correction of the problem. In a manual customer complaint system, customer complaints may come from different sources (e-mail, phone, fax, letters, corporate website, sales reps, etc.). These complaints may languish in someone's inbox, especially if there is no formal and standard procedure for processing them. Without a cohesive structure that captures complete information in a timely manner, it is almost impossible to formulate a strategy for complaint resolution. A single, cohesive system simplifies the search and retrieval of complaints and related data. A software solution-as opposed to a paper-based system-offers the capability to formalize and standardize complaint handling through a simple web-based process, so customers can log sample customer complaints from virtually anywhere. And complaint handlers can manage those complaints from any location with internet access as well.

Integration with Other Computerized Business Systems: An automated system connects the customer complaint process to the rest of the quality system and should provide links to corrective actions and adverse-event handling tools. This connectivity with the sample customer complaints helps managers track a complaint from initiation to completion. When a company uses multiple disconnected tools and follow-ups are not recorded through the manual customer complaint system, tracking complaints and follow-up work can be a major obstacle to conducting business successfully. If there is no standardized response to complaints, the required documentation falls through the cracks and delays the correction of problems. With an effective electronic system, a link can be provided on a company website within a CRM application (or any application that supports URL links), so employees, customers, or partners can easily initiate a customer complaint. Connectivity with these sample customer complaints will help managers track a complaint from initiation to completion and give them the ability to proactively improve the complaint-handling process.

Efficiency: A manual system is plagued by bottlenecks: misplaced or overlooked complaints coming from disparate sources, incomplete information, lack of follow up, and inadequate response. All of these can result in delayed complaint resolution. Electronic systems that are dedicated to the management of sample customer complaints reduce the life cycle of the complaint process by streamlining processes and consolidating different sources under a single platform. Some electronic systems provide customizable forms that capture all essential information, feature automatic follow-up email notifications, and incorporate escalations to ensure timely responses.

Mitigation of Potential Legal Issues: In a manual customer complaint system, record keeping may be inadequate if the company is ever required to respond to a product liability lawsuit. Paper-based systems don't give managers the ability to track complaints and see the compliance program as a whole, both of which are essential in developing a strategy to prevent unwarranted legal exposure. Customer complaint software can give a company advanced reporting tools that provide a real-time view of the state of the company's compliance. With continuous monitoring capabilities, an organization can be prepared to respond to any potential lawsuits. A controlled record-keeping environment that shows how complaints are investigated and addressed may help reduce legal risks.

Examples of Customer Complaint Software Features

Robust complaint handling software solutions should include most or all of the following features and functionality:

Simple Three-Step Process - Cutting-edge customer complaint handling software should be based on industry best- practice processes and incorporate pre-configured, multi-page customer complaint forms. The complaint management process should begin with the initiation of a customer complaint by a coordinator or manager. The system should then automatically move to an internal investigation phase (conducted either by an expert or a team of experts). The third and final step culminates with a resolution of the issue as approved by the appropriate manager. Additional customizable forms tailored to suit the company's special needs should also be available.

Compliant System - Organizations doing business in regulatory environments require an electronic system that is designed to meet their regulatory needs. Companies subject to ISO and FDA guidelines cannot ignore customer complaints. They are the ultimate indicators of product/service quality. Every complaint has to be properly evaluated, investigated, and corrected. For instance, the FDA's 21 CFR Part 11 requires an audit trail as a key control in making electronic records reliable. Customers subject to such regulatory standards require a secure, time-stamped audit trail that documents the identity of anyone who creates, modifies, or deletes an electronic record (such as a sample customer complaint file), when the action occurred, and the changes made to the record. If your organization is subject to regulatory compliance, there are many systems on the market that are specifically engineered to facilitate compliance with regulatory requirements like FDA standards and guidelines such as ISO 9000, ISO 14000, and ISO 13485. A good system should not only help you attain FDA and ISO compliance, but should also help you sustain it year after year.

Analytics and Reporting Tools - Advanced reporting capabilities that are built into quality software should increase management oversight and demonstrate appropriate controls to regulatory agencies. High-caliber software solutions designed to manage customer complaints should include the following types of reports:

Complaint summary

In-process customer complaints

Complaints categorized by type, product, and department

Trending categorized by complaint type, product, and department

CAPA Integration - Software systems that integrate customer complaints with the overall quality system should also connect with the corrective and preventive action CAPA process in order to automatically escalate any serious quality problems.

For More Information on Customer Complaint Software

If you would like to learn more about sample customer complaint forms and electronic quality solutions, feel free to contact a MasterControl representative.